(76 days)
Prime-Dent® Chemical Cure Pit & Fissure Sealant (opaque and clear) is a BisGMA I Time-Dome Chomical Casin for the sealing of deciduos teeth and the filling of fissures in primary tooth structure.
Not Found
I am sorry, but the provided text from the FDA 510(k) summary for "Prime-Dent Chemical Cure Pit & Fissure Sealant" (K012794) does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The document is a letter from the FDA to the manufacturer, indicating that the device has been found substantially equivalent to a predicate device and can be marketed. It refers to the device's indications for use but does not delve into the detailed performance data that would typically be found in a study report.
Therefore, I cannot provide the requested table and study details based on the given information.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 5 2001
Mr. Roland Marasigan Vice President of Manufacturing Prime Dental Manufacturing, Incorporated 3735 West Belmont Avenue Chicago, Illinois 60618
Re: K012794
Trade/Device Name: Prime-Dent Chemical Cure Pit & Fissure Sealant Regulation Number: 872.3765 Regulation Name: Sealant Regulatory Class: II Product Code: EBC Dated: August 14, 2001 Received: August 21, 2001
Dear Mr. Marasigan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements
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Page 2 - Mr. Marasigan
of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
[signature]
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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NOV 0 5 2001
Indications for Use
Prime-Dent® Chemical Cure Pit & Fissure Sealant (opaque and clear) is a BisGMA I Time-Dome Chomical Casin for the sealing of deciduos teeth and the filling of fissures in primary tooth structure.
Susan Runoes
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ ...
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.